Beginners Guide: UDI for Unique Device Identification (Medical Device regulation)
Monir El Azzouzi
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
The UDI or “Unique Identification Number” is one of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746.
This element will be key for the traceability of devices in Europe. It′s not something new on the Medical Device Industry as it′s also a requirement for products delivered to the US.
But for manufacturers that are not selling their products in the United States of America, there will be some work to do.
I was initially expecting to issue this topic when there will be more clarity on the companies that will be allowed to provide the identification numbers.
But I discovered after reading many times the EU MDR that it′s already done if I can say (lol).
So, I decided to provide you with the information I have now and maybe, update this article when there will be more information.
Senior Regulatory Affairs Manager
5 年Dear Monir, Thank you for all your posts, youtube movies and mini-course. They are great and very helpful. Do you think we can use the same basic UDI for two products with the same intended use when one is in liquid form and the other one is a dispersible tablet which once dissolved in a glass of water become the same the liquid form? obviously the manufacturer process is different.?